Registration Dossier
Registration Dossier
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EC number: 299-370-6 | CAS number: 93859-32-6
Endpoint summary
Administrative data
Link to relevant study record(s)
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Description of key information
The Annex VIII of the REACH regulation requires an assessment of the toxicokinetic behavior of the substance to the extent that can be derived from the relevant available information. There is no available data on the toxicokinetics of the chemical sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2,3-dihydro-1,3-benzoxazole-2-sulfonate. Toxicokinetics is essentially the study of "how a substance gets into the body and what happens to it in the body". Four processes are involved in toxicokinetics; namely absorption, distribution, metabolism and excretion (ADME). It may be noted that the chemical sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2,3-dihydro-1,3-benzoxazole-2-sulfonate is a fluorescent color having applications such as use in manufacturing of Dyestuff application, Colouring agent and dye and Pharma intermediate. Since the chemical is not a food dye, it is unlikely to be ingested and there is a low possibility of the chemical exerting a toxic effect after ingestion. A Log Pow of 1.141 ± 0.047 is experimental and hence the bioavailability &bioaccumulation potential of sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2,3-dihydro-1,3-benzoxazole-2-sulfonate is expected to be low. Thus, these chemicals even if ingested are expected to be excreted out of the human body unchanged. In addition, the particle size distribution of the chemical was found to be in the range of 150 micron to 10 micron. Thus, the likelihood of inhalation of these particles is low. Thus, considering the use of this chemical as well as the fact that oral and inhalation exposure are very unlikely, the end point of toxico-kinetics was considered for waiver.
Key value for chemical safety assessment
Additional information
The Annex VIII of the REACH regulation requires an assessment of the toxicokinetic behavior of the substance to the extent that can be derived from the relevant available information. There is no available data on the toxicokinetics of the chemical sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2,3-dihydro-1,3-benzoxazole-2-sulfonate. Toxicokinetics is essentially the study of "how a substance gets into the body and what happens to it in the body". Four processes are involved in toxicokinetics; namely absorption, distribution, metabolism and excretion (ADME). It may be noted that the chemical sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2,3-dihydro-1,3-benzoxazole-2-sulfonate is a fluorescent color having applications such as use in manufacturing of Dyestuff application, Colouring agent and dye and Pharma intermediate. Since the chemical is not a food dye, it is unlikely to be ingested and there is a low possibility of the chemical exerting a toxic effect after ingestion. A Log Pow of 1.141 ± 0.047 is experimental and hence the bioavailability &bioaccumulation potential of sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2,3-dihydro-1,3-benzoxazole-2-sulfonate is expected to be low. Thus, these chemicals even if ingested are expected to be excreted out of the human body unchanged. In addition, the particle size distribution of the chemical was found to be in the range of 150 micron to 10 micron. Thus, the likelihood of inhalation of these particles is low. Thus, considering the use of this chemical as well as the fact that oral and inhalation exposure are very unlikely, the end point of toxico-kinetics was considered for waiver.
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